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Name /bks_53161_deglins_md_disk/risperidone 02/17/2014 09:54AM Plate # 0-Composite pg 1 # 1 TIME/ACTION PROFILE (clinical effects) 1 risperidone (riss-per-i-done) Risperdal, Risperdal M-TAB, Risperdal Consta Classification Therapeutic: antipsychotics, mood stabilizers Pharmacologic: benzisoxazoles Pregnancy Category C ROUTE ONSET PEAK DURATION PO IM 1–2 wk 3 wk unknown 4– 6 wk up to 6 wk† up to 6 wk† †After discontinuation Contraindications/Precautions Contraindicated in: Hypersensitivity; Lactation: Discontinue drug or bottle feed. Use Cautiously in: Debilitated patients, patients with renal or hepatic impairment Indications Schizophrenia in adults and adolescents age 13– 17 yr. Short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder (oral only) in adults, and children and adolescents aged 10– 17 yr, maintenance treatment of Bipolar I Disorder (IM only) in adults only; can be used with lithium or valproate (adults only). Irritability associated with autistic disorder in children. Action May act by antagonizing dopamine and serotonin in the CNS. Therapeutic Effects: Decreased symptoms of psychoses, bipolar mania, or autism. Pharmacokinetics Absorption: 70% after administration of tablets, solution or orally disintegrating tablets. Following IM administration, small initial release of drug, followed by 3– wk lag ; the rest of release starts at 3 wk and lasts 4– 6 wk. Distribution: Unknown. Metabolism and Excretion: Extensively metabolized by the liver. Metabolism is genetically determined; extensive metabolizers (most patients) convert risperidone to 9-hydroxyrisperidone rapidly. Poor metabolizers (6– 8% of Whites) convert it more slowly. The 9-hydroxyrisperidone is an antipsychotic compound. Risperidone and its active metabolite are renally eliminated. Half-life: Extensive metabolizers— 3 hr for risperidone, 21 hr for 9-hydroxyrisperidone. Poor metabolizers— 20 hr for risperidone and 30 hr for 9-hydroxyrisperidone. ⫽ Canadian drug name. ⫽ Genetic Implication. (initial dose reduction recommended); Underlying cardiovascular disease (qrisk of arrhythmias and hypotension); History of seizures; History of suicide attempt or drug abuse; Diabetes or risk factors for diabetes (may worsen glucose control); Patients at risk for aspiration; OB, Pedi: Safety not established; Geri: Initial doseprecommended.qrisk of mortality in elderly patients treated for dementia-related psychosis. Adverse Reactions/Side Effects CNS: NEUROLEPTIC MALIGNANT SYNDROME, SUICIDAL THOUGHTS, aggressive behavior, dizziness, extrapyramidal reactions, headache,qdreams,qsleep duration, insomnia, sedation, fatigue, impaired temperature regulation, nervousness, tardive dyskinesia. EENT: pharyngitis, rhinitis, visual disturbances. Resp: cough, dyspnea. CV: arrhythmias, orthostatic hypotension, tachycardia. GI: constipation, diarrhea, dry mouth, nausea, weight gain, abdominal pain, anorexia, dyspepsia, polydipsia,qsalivation, vomiting, weight loss. GU: plibido, dysmenorrhea/menorrhagia, difficulty urinating, polyuria, priapism. Derm: itching/skin rash, dry skin,qpigmentation, sweating, photosensitivity, seborrhea. Endo: dyslipidemia, galactorrhea, hyperglycemia. Hemat: AGRANULOCYTOSIS, leukopenia, neutropenia. MS: arthralgia, back pain. Interactions Drug-Drug: Maypthe antiparkinsonian effects of levodopa or other dopamine agonists. Carbamazepine, phenytoin, rifampin, phenobarbital, and other enzyme inducersqmetabolism and maypeffectiveness; dose adjustments may be necessary. Fluoxetine and paroxetineqblood levels and mayqeffects; dose adjustments may be necessary. Clozapinepmetabolism and mayqeffects of risperidone. CAPITALS indicate life-threatening, underlines indicate most frequent. Strikethrough ⫽ Discontinued. PDF Page #1 Name /bks_53161_deglins_md_disk/risperidone 02/17/2014 09:54AM 2 qCNS depression may occur with other CNS depressants, including alcohol, antihistamines, sedative/hypnotics, or opioid analgesics. Drug-Natural Products: Kava, valerian, or chamomile canqCNS depression. Route/Dosage Schizophrenia PO (Adults): 1 mg twice daily,qby 1– 2 mg/day no more frequently than every 24 hr to 4– 8 mg daily. PO (Children 13– 17 yr): 0.5 mg once daily,qby 0.5– 1.0 mg no more frequently than every 24 hr to 3 mg daily. May administer half the daily dose twice daily if drowsiness persists. IM (Adults): 25 mg every 2 wk; some patients may benefit from a higher dose of 37.5 or 50 mg every 2 wk. Plate # 0-Composite pg 2 # 2 Renal Impairment Hepatic Impairment PO (Adults): Start with 0.5 mg twice daily;qby 0.5 mg twice daily, up to 1.5 mg twice daily; thenqat weekly intervals if necessary. May also be given as a single daily dose after initial titration. NURSING IMPLICATIONS Assessment ● Monitor patient’s mental status (orientation, mood, behavior) and mood before ● Acute Manic or Mixed Episodes Associated with Bipolar I Disorder PO (Adults): 2– 3 mg/day as a single daily dose, dose may beqat 24– hr intervals by ● 1 mg (range 1– 5 mg/day). PO (Children 13– 17 yr): 0.5 mg once daily,qby 0.5– 1 mg no more frequently than every 24 hr to 2.5 mg daily. May administer half the daily dose twice daily if ● drowsiness persists. PO (Geriatric Patients or Debilitated Patients): Start with 0.5 mg twice daily;q ● by 0.5 mg twice daily, up to 1.5 mg twice daily; thenqat weekly intervals if necessary. May also be given as a single daily dose after initial titration. Maintenance Treatment of Bipolar I Disorder IM (Adults): 25 mg every 2 wk; some patients may benefit from a higher dose of 37.5 or 50 mg every 2 wk. ● Irritability Associated with Autistic Disorder ● PO (Children 5– 16 yr weighing ⬍20 kg): 0.25 mg/day initially. After at least 4 days of therapy, mayqto 0.5 mg/day. Doseqin increments of 0.25 mg/day may be considered at 2-wk or longer intervals. May be as a single or divided dose. PO (Children 5– 16 yr weighing ⬎20 kg): 0.5 mg/day initially. After at least 4 days of therapy, mayqto 1 mg/day. Doseqin increments of 0.5 mg/day may be considered at 2-wk or longer intervals. May be as a single or divided dose. ● ● ● and periodically during therapy. Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression, especially during early therapy. Restrict amount of drug available to patient. Assess weight and BMI initially and throughout therapy. Monitor for symptoms of hyperglycemia polydipsia, polyuria, polyphagia,weakness) periodically during therapy. Monitor BP (sitting, standing, lying down) and pulse before and frequently during initial dose titration. May cause prolonged QT interval, tachycardia, and orthostatic hypotension. If hypotension occurs, dose may need to be decreased. Observe patient when administering medication to ensure medication is swallowed and not hoarded or cheeked. Monitor patient for onset of extrapyramidal side effects (akathisia— restlessness; dystonia— muscle spasms and twisting motions; or pseudoparkinsonism— mask-like face, rigidity, tremors, drooling, shuffling gait, dysphagia). Report these symptoms; reduction of dose or discontinuation may be necessary. Trihexyphenidyl or benztropine may be used to control symptoms. Monitor for tardive dyskinesia (involuntary rhythmic movement of mouth, face, and extremities). Report immediately; may be irreversible. Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness). Notify health care professional immediately if these symptoms occur. Lab Test Considerations: May causeqserum prolactin levels. May causeqAST and ALT. May also cause anemia, thrombocytopenia, leukocytosis, and leukopenia. 䉷 2015 F.A. Davis Company CONTINUED PDF Page #2 Name /bks_53161_deglins_md_disk/risperidone 02/17/2014 09:54AM 3 Plate # 0-Composite pg 3 # 3 safety needle; alternate arms or buttocks with each injection. Allow solution to warm to room temperature prior to injection. Administer immediately after mixed with diluent; shake well to mix suspension. Must be administered within 6 hr of reconstitution. Store dose pack in refrigerator. ● Do not combine dose strengths in a single injection. CONTINUED risperidone ● Obtain fasting blood glucose and cholesterol levels initially and periodically dur- ing therapy. ● Monitor CBC frequently during initial months of therapy in patients with pre-exist- ing or history of low WBC. May cause leukopenia, neutropenia, or agranulocytosis. Discontinue therapy if this occurs. Patient/Family Teaching ● Instruct patient to take medication as directed. ● Inform patient of the possibility of extrapyramidal symptoms. Instruct patient to report these symptoms immediately to health care professional. ● Advise patient to change positions slowly to minimize orthostatic hypotension. ● May cause drowsiness. Caution patient to avoid driving or other activities requir- Potential Nursing Diagnoses Risk for self-directed violence (Indications) Disturbed thought process (Indications) Risk for injury (Side Effects) ing alertness until response to medication is known. ● Advise patient and family to notify health care professional if thoughts Implementation ● Do not confuse risperidone with reserpine. ● When switching from other antipsychotics, discontinue previous agents when starting risperidone and minimize the period of overlapping antipsychotic agents. ● If therapy is reinstituted after an interval off risperidone, follow initial titration schedule. ● ● For IM use, establish tolerance with oral dosing before IM use and continue oral ● ● ● ● dosing for 3 wk following initial IM injection. Do not increase dose more frequently than every 4 wk. PO: Daily doses can be taken in the morning or evening. For orally disintegrating tablets, open blister pack by pealing back foil to expose tablet; do not try to push tablet through foil. Use dry hands to remove tablet from blister and immediately place entire tablet on tongue. Tablets disintegrate in mouth within seconds and can be swallowed with or without liquid. Do not attempt to split or chew tablet. Do not try to store tablets once removed from blister. Oral solution can be mixed with water, coffee, orange juice, or low fat milk; do not mix with cola or tea. IM: Reconstitute with 2 mL of diluent provided by manufacturer. Administer via deep deltoid (1-inch needle) or gluteal (2-inch needle) injection using enclosed ⫽ Canadian drug name. ⫽ Genetic Implication. ● ● ● ● ● about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking, other unusual changes in behavior or mood occur. Advise patient to use sunscreen and protective clothing when exposed to the sun to prevent photosensitivity reactions. Extremes in temperature should also be avoided; this drug impairs body temperature regulation. Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Caution patient to avoid concurrent use of alcohol and other CNS depressants. Advise female patients to notify health care professional if pregnancy is planned or suspected, or if breast feeding or planning to breast feed. Advise patient to notify health care professional of medication regimen before treatment or surgery. Instruct patient to notify health care professional promptly if sore throat, fever, unusual bleeding or bruising, rash, tremors or symptoms of hyperglycemia occur. Emphasize the importance of routine follow up exams to monitor side effects and continued participation in psychotherapy to improve coping skills. CAPITALS indicate life-threatening, underlines indicate most frequent. Strikethrough ⫽ Discontinued. PDF Page #3 Name /bks_53161_deglins_md_disk/risperidone 02/17/2014 09:54AM Plate # 0-Composite pg 4 # 4 4 PDF Page #4 Evaluation/Desired Outcomes ● Decrease in excited, manic behavior. ● Decrease in positive symptoms (delusions, hallucinations) of schizophrenia. ● Decreased aggression toward others, deliberate self— injury, temper tantrums, and mood changes in children with autism. ● Decrease in negative symptoms (social withdrawal, flat, blunted affects) of schizo- phrenia. ● Decrease in autism symptoms. Why was this drug prescribed for your patient? 䉷 2015 F.A. Davis Company